Establishing the methodology for the conduct of prospective clinical trials in SCT, in accordance with the EU Directive on Clinical Trials and standards of Good Clinical Practice (GCP) in Europe
The key objectives of this Work Package are to:
- develop a Review Process for the approval of EBMT clinical trials
- develop Standard Operating Procedures (SOPs) for the conduct of EBMT trials
- benefit from the advice and support of Industry partners on clinical trials’ management
- to conduct academic led clinical trials following the processes implemented
Under the direction of Zoë Doran (Director, EBMT Clinical Trials Operations) and with the support of Gerard Socié (Chair of the EBMT Prospective Clinical Trials Committee) and Kim Champion (EBMT Clinical Trials Operations Manager) an internal review process for EBMT sponsored trials has been developed and is currently being implemented. The Prospective Clinical Trials Committee (PCTC) will review proposals submitted by the EBMT Working Parties on a bi-annual basis to assess their scientific value and compliance with standards of GCP. Those approved will be prioritised and the recommendations of the committee presented to the EBMT Board at 6 monthly intervals for a final decision regarding scientific priority and use of central resources. A more detailed overview of the review process and the structure and remit of the PCTC is included on the clinical trials section of this website and a pdf copy is available for download in the project deliverables table below (D13).
A core set of Standard Operation Procedures (SOPs) has been produced and these are currently being expanded and updated to ensure that the EBMT is able to meet standards required for Registration-level clinical trials’ management. The current SOPs are available for consultation on the clinical trials section of this website. SOP reading and training logs are in place for all staff.
The EBMT enjoys a positive, collaborative relationship with its Corporate Patrons and as part of the project is exploring with them the best way to harness Industry knowledge and experience in developing the EBMT’s infrastructure and capacity for running trials under the EU Directive. Ad hoc advice is sought from Corporate Patrons regarding infrastructure, regulations, safety data, etc.
The project has also provided the opportunity for the EBMT and CIBMTR to share experience of trials management across the Atlantic, with a view to raising the overall quality of multi-centre clinical trials in the field of stem cell transplantation. The experience of CIBMTR through their association with the Blood and Marrow Clinical Trials Network (BMT CTN) in the USA has proved beneficial in this regard.
Deliverables: April 2007 – September 2009
||Meeting reports of the Industry Advisory Committee
||M6, 12, 18 , 24
||Report on supportive interactions with Industry partners prepared at month 30|
Standard Operating Procedures for conduct of clinical studies:
- Remit of the Prospective Clinical Trials Committee
- Overview of SOPs in place and under development
|Months 12, 24
Remit document (31/03/2008)
Link to SOPs section
||Trial protocols and annual study accrual figures
||Month 18, 24
|| Link to Trials overview|
||Analysis of the conduct of clinical studies
Report on conduct of clinical trials within EBMT
||Meeting reports of Priority Review Committee
|| Report on EBMT clinical trials sign-off process|